by ACRE Aps
DK-MF-000010025 · Denmark · Copenhagen
by ACRE Aps is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 36 |
|---|
Devices declared under this manufacturer
- CO - M Midnight Blue
- CO - M Rose Gold
- CU - CT Champagne Gold
- CU - CT Strawberry Red
- CU - RT British Racing Green
- CU - WT British Racing Green
- CU - WT Champagne Gold
- CU - WT Royal Blue
- NP - M Army
- NP - M Baltic Blue
- NP - M Glacier Green
- NP - M Navy
Showing 12 of 36 declared devices.
Catalogue references include 05713504000036, 05713504003426, 05713504003495, 05713504005000, 05713504005031, 05713504005789.
European nomenclature codes declared: Y120606.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BY ACRE APS (DK) · FDA 3015781799 |
| Devices in EUDAMED | 36 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 36 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. by ACRE Aps is registered in the United States but was not found in the Canadian register.